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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Brush, Dermabrasion, Powered
510(k) Number K905046
Device Name DERMABRADER
Applicant
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Applicant Contact ROBERT SARON
Correspondent
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Correspondent Contact ROBERT SARON
Regulation Number878.4820
Classification Product Code
GFE  
Date Received11/08/1990
Decision Date 12/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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